# China NMPA Inspection - Hunan Changfa Fengyuan Pharmaceutical Co., Ltd. - November 07, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-changfa-fengyuan-pharmaceutical-co-ltd/5000a180-d695-42a1-a9ac-369402ffca05/
Source feed: China

> China NMPA unannounced inspection for Hunan Changfa Fengyuan Pharmaceutical Co., Ltd. published November 07, 2016. The Hunan Provincial Food and Drug Administration conducted unannounced inspections of six drug wholesale enterprises in 2016, under its Drug Distribu

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement from the Hunan Provincial Food and Drug Administration Regarding the First Batch of Unannounced Inspections and Handling of Drug Distribution in 2016
- Company Name: Hunan Changfa Fengyuan Pharmaceutical Co., Ltd.
- Publication Date: 2016-11-07
- Product Type: Drugs
- Summary: The Hunan Provincial Food and Drug Administration conducted unannounced inspections of six drug wholesale enterprises in 2016, under its Drug Distribution Surprise Inspection Plan. These inspections aimed to ensure compliance with pharmaceutical Good Supply Practice (GSP) regulations, with results announced on August 22, 2016. Significant violations led to severe regulatory actions for several companies. Hunan Changfa Fengyuan Pharmaceutical Co., Ltd., Xiangtan Hengjian Pharmaceutical Co., Ltd., and Loudi Huatai Pharmaceutical Co., Ltd. all had their GSP certifications revoked. Common critical issues included substantial discrepancies in temperature monitoring systems, failure of these systems to alarm for temperature excursions, inadequate drug storage conditions (e.g., incorrect temperatures, co-storage with non-pharmaceuticals), and deficiencies in quality management systems, computer systems, and record-keeping. These cases were transferred for further investigation and legal action. Yueyang Kang'er Pharmaceutical Co., Ltd. and Yiyang Sanhe Pharmaceutical Co., Ltd. were ordered to rectify issues within a specified period, including improper cash transactions for certain drugs and data entry errors. Suspected illegal activities were also referred for further investigation. Lastly, Hunan Da Senlin Pharmaceutical Co., Ltd. voluntarily cancelled its drug business license and GSP certificate, halting its inspection.

Company: https://www.globalkeysolutions.net/companies/hunan-changfa-fengyuan-pharmaceutical-co-ltd/e6087517-495b-42e2-8448-a075112be550/